Skip to content
Triangle logo TriangleGet started
← Study library

NCT05537766 · REGISTRY CONDITION SEARCH

Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2026-03-10

Master protocol: The goal of this master clinical study is to test how well the study drug, brexucabtagene autoleucel, works in participants with rare B-cell malignancies: relapsed/refractory Waldenstrom macroglobulinemia (r/r WM) (Substudy A), r/r Richter transformation (RT) (Substudy B), r/r Burkitt lymphoma (BL) (Substudy C) and r/r hairy cell leukemia (HCL) (Substudy D).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Substudy A: Combined Rate of Complete Response (CR) and Very Good Partial Response (VGPR) Determined by Central Assessment Per the Sixth International Workshop in Waldenstrom Macroglobulinemia (WM)

→

outcome · POSTED

Substudy B: Objective Response Rate (ORR) Determined by Central Assessment Per the Lugano Classification

→

outcome · POSTED

Substudy C: ORR Determined by Central Assessment Per the Lugano Classification

→

outcome · POSTED

Substudy D: ORR Determined by Central Assessment Per the Response Criteria Described by Grever and Colleagues

→

outcome · POSTED

All Substudies (Substudies A, B, C and D): Complete Response (CR) Rate Determined by Central Assessment

→

outcome · POSTED

All Substudies (Substudies A, B, C and D): Duration of Response (DOR)

→

outcome · POSTED

All Substudies (Substudies A, B, C and D): Overall Survival (OS)

→

outcome · POSTED

All Substudies (Substudies A, B, C and D): Progression Free Survival (PFS)

→

outcome · POSTED

All Substudies (Substudies A, B, C and D): Time to Next Treatment (TTNT)

→

outcome · POSTED

All Substudies (Substudies A, B, C and D): Time to First Objective Response

→

outcome · POSTED

All Substudies (Substudies A, B, C and D): Time to Best Objective Response

→

outcome · POSTED

All Substudies (Substudies A, B, C and D): Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

→

outcome · POSTED

All Substudies (Substudies A, B, C and D): Number of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher

→

outcome · POSTED

All Substudies (Substudies A, B, C and D): Number of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher

→

outcome · POSTED

All Substudies (Substudies A, B, C and D): Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs)

→

outcome · POSTED

All Substudies (Substudies A, B, C and D): Number of Participants With Positive Anti-brexucabtagene Autoleucel Antibodies

→

outcome · POSTED

All Substudies (Substudies A, B, C and D): Number of Participants With Replication-competent Retrovirus (RCR) in Peripheral Blood Mononuclear Cells (PBMCs)

→

outcome · POSTED

All Substudies (Substudies A, B, C and D): Number of Participants With Deterioration Scores From Screening in the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30)

→

outcome · POSTED

All Substudies (Substudies A, B, C and D): Number of Participants With Deterioration Scores From Screening in the European Quality of Life Five Dimensions Five Levels Questionnaire (EQ-5D-5L)

→

outcome · POSTED

All Substudies (Substudies A, B, C and D): Change From Screening in the EQ-ED-5L Visual Analogue Scale (EQ-VAS) Score

→

outcome · POSTED

Substudy A: ORR (CR, VGPR, or PR) Determined by Central Assessment Per the Sixth International Workshop in WM

→

outcome · POSTED

Substudy A: Percentage of Participants With Combined CR and VGPR Determined by Investigator Assessment Per the Sixth International Workshop in WM

→

outcome · POSTED

Substudy A: PR Rate Determined by Central Assessment Per the Sixth International Workshop in WM

→

outcome · POSTED

Substudy A: VGPR Rate Determined by Central Assessment Per the Sixth International Workshop in WM

→

outcome · POSTED

Substudy B: Number of Participants With OR Determined by Investigator Assessment Per the Lugano Classification

→

outcome · POSTED

Substudy B: Number of Participants With OR Based on Clonal Relationship to the Underlying CLL by Central Assessment Per the Lugano Classification

→

outcome · POSTED

Substudy B: Number of Participants With OR (CR, CRi, or PR) Determined by Investigator Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 Criteria

→

outcome · POSTED

Substudy C: Number of Participants With OR Determined by Investigator Assessment Per the Lugano Classification

→

outcome · POSTED

Substudy D: Number of Participants With OR Determined by Investigator Assessment Per Grever and Colleagues

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Key Inclusion Criteria: All Substudies: * Presence of toxicities due to prior therapy must be stable and recovered to Grade 1 or lower. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Adequate hematologic and end-organ function. * Individuals of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception. Substudy B: * Confirmed diagnosis of chronic lymphocytic leukemia (CLL) based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria with histologically confirmed Richter transformation (RT) to a diffuse large B-cell lymphoma (DLBCL) subtype. * Relapsed or refractory disease after 1 line of therapy, defined as at least 1 of the following: * Refractory disease, defined as progressive disease or stable disease as best response to first-line therapy. * Relapsed disease, defined as complete remission to first-line therapy followed by biopsy-proven disease relapse. * At least 1 measurable lesion based on the Lugano Classification. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. Substudy C: * Histologically confirmed mature B-cell non-Hodgkin lymphoma (NHL) Burkitt lymphoma/leukemia. * Relapsed or refractory disease after first-line chemoimmunotherapy, defined as 1 of the following: * Refractory disease, defined as progressive disease or stable disease as best response to first-line therapy; individuals who are intolerant to first-line therapy are excluded. * Relapsed disease, defined as complete remission to first-line therapy followed by biopsy-proven disease relapse. * At least 1 measurable lesion based on the Lugano Classification. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. Key Exclusion Criteria: All Substudies: * Prior chimeric antigen receptor (CAR) therapy or treatment with any anti-Cluster of Differentiation 19 (CD19) therapy. * human immunodeficiency virus (HIV)-positive patients, unless taking appropriate anti-HIV medications, having an undetectable viral load by quantitative polymerase chain reaction (qPCR) and a CD4 count \> 200 cells/μL. * Presence of detectable cerebrospinal fluid malignant cells or brain metastases. * History of autoimmune disease (eg, Crohn's disease, rheumatoid arthritis, systemic lupus). Substudy B: * Diagnosis of RT not of DLBCL subtype (including, but not limited to, Hodgkin lymphoma (HL) and prolymphocytic leukemia). * Prior allogeneic or autologous stem cell transplant \< 3 months prior to screening and/or \< 4 months prior to planned infusion of brexucabtagene autoleucel. * Presence of active graft-versus-host disease following prior stem cell transplant. Substudy C: * Burkitt-like lymphoma with 11q aberration, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement, or high-grade B-cell lymphoma not otherwise specified. * Prior allogeneic stem cell transplant \< 3 months prior to screening and/or \< 4 months prior to planned infusion of brexucabtagene autoleucel. * Presence of active graft-versus-host disease following prior allogeneic stem cell transplant. * Presence of central nervous system (CNS) involvement. Individuals with a prior history of CNS involvement are eligible if they show a negative cerebrospinal fluid (CSF) and no involvement by imaging. Substudies A and D have been early terminated by the sponsor. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants with Relapsed/Refractory Waldenstrom Macroglobulinemia will receive the following treatment during the study:Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day intravenously (IV) and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) T cells/kg on Day 0.
    intervention Names
    1. Biological: Brexucabtagene Autoleucel
    2. Drug: Cyclophosphamide
    3. Drug: Fludarabine
    label
    Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel
    type
    EXPERIMENTAL
  2. description
    Participants with Relapsed/Refractory Richter Transformation will receive the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3).A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
    intervention Names
    1. Biological: Brexucabtagene Autoleucel
    2. Drug: Cyclophosphamide
    3. Drug: Fludarabine
    label
    Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
    type
    EXPERIMENTAL
  3. description
    Participants with Relapsed/Refractory Burkitt Lymphoma will receive the following treatment during the study:Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3).A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
    intervention Names
    1. Biological: Brexucabtagene Autoleucel
    2. Drug: Cyclophosphamide
    3. Drug: Fludarabine
    label
    Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
    type
    EXPERIMENTAL
  4. description
    Participant with Relapsed/Refractory Hairy Cell Leukemia will receive the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
    intervention Names
    1. Biological: Brexucabtagene Autoleucel
    2. Drug: Cyclophosphamide
    3. Drug: Fludarabine
    label
    Substudy D (Relapsed/Refractory hairy cell leukemia): Brexucabtagene Autoleucel
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel
    2. Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
    3. Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
    4. Substudy D (Relapsed/Refractory hairy cell leukemia): Brexucabtagene Autoleucel
    description
    Administered intravenously
    name
    Brexucabtagene Autoleucel
    other Names
    1. KTE-X19
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel
    2. Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
    3. Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
    4. Substudy D (Relapsed/Refractory hairy cell leukemia): Brexucabtagene Autoleucel
    description
    Administered intravenously
    name
    Cyclophosphamide
    type
    DRUG
  3. arm Group Labels
    1. Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel
    2. Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
    3. Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
    4. Substudy D (Relapsed/Refractory hairy cell leukemia): Brexucabtagene Autoleucel
    description
    Administered intravenously
    name
    Fludarabine
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
19
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The combined rate of CR and VGPR was defined as the percentage of participants who achieved a best response of either CR or VGPR per the Sixth International Workshop in WM.
    measure
    Substudy A: Combined Rate of Complete Response (CR) and Very Good Partial Response (VGPR) Determined by Central Assessment Per the Sixth International Workshop in Waldenstrom Macroglobulinemia (WM)
    time Frame
    Up to 2 years
  2. description
    ORR was defined as the percentage of participants who achieved a best response of either CR or PR per the Lugano Classification.
    measure
    Substudy B: Objective Response Rate (ORR) Determined by Central Assessment Per the Lugano Classification
    time Frame
    Up to 2 years
  3. description
    ORR was defined as the percentage of participants who achieved a best response of either CR or PR per the Lugano Classification.
    measure
    Substudy C: ORR Determined by Central Assessment Per the Lugano Classification
    time Frame
    Up to 2 years
  4. description
    ORR was defined as the percentage of participants who achieved a best response of either CR or PR per Grever and colleagues. CR: Near normalization of peripheral blood counts: hemoglobin \>11 g/dL (without transfusion); platelets \>100 000/μL; absolute neutrophil count \>1500/μL. Regression of splenomegaly on physical examination. Absence of morphologic evidence of HCL on both the peripheral blood smear and the bone marrow examination. PR: PR required near normalization of the peripheral blood count (as in CR) with a minimum of 50% improvement in organomegaly and bone marrow biopsy infiltration with HCL.
    measure
    Substudy D: ORR Determined by Central Assessment Per the Response Criteria Described by Grever and Colleagues
    time Frame
    Up to 2 years
secondary Outcomes
  1. description
    CR Rate is defined as the percentage of participants with CR.
    measure
    All Substudies (Substudies A, B, C and D): Complete Response (CR) Rate Determined by Central Assessment
    time Frame
    Up to 2 years
  2. description
    DOR was defined as time from first objective response (OR) to disease progression (PD) or death. OR is defined in OM#25 (Substudy B), 28 (Substudy C), and 29 (Substudy D). PD: score 4 (uptake moderately \>liver) or 5 (uptake markedly\>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow.
    measure
    All Substudies (Substudies A, B, C and D): Duration of Response (DOR)
    time Frame
    Up to 2 years
  3. description
    OS was defined as the time from the date of brexucabtagene autoleucel infusion to the date of death from any cause.
    measure
    All Substudies (Substudies A, B, C and D): Overall Survival (OS)
    time Frame
    Up to 2 years
  4. description
    PFS was defined as the time from the date of brexucabtagene autoleucel infusion to the date of PD or death from any cause. PD is defined in outcome measure #6.
    measure
    All Substudies (Substudies A, B, C and D): Progression Free Survival (PFS)
    time Frame
    Up to 2 years
  5. description
    TTNT defined as the time from the date of brexucabtagene autoleucel infusion to the start of new anti-cancer (including stem cell transplant) therapy prior to documented progression, or death from any cause. KM estimates were used in the outcome measure analysis.
    measure
    All Substudies (Substudies A, B, C and D): Time to Next Treatment (TTNT)
    time Frame
    Up to 2 years
  6. description
    Time to first objective response was defined as time from the date of brexucabtagene autoleucel infusion to the date of first response per the Sixth International Workshop in WM for r/rWM, per the Lugano Classification for r/rRT and r/r BL, and per Grever and colleagues for r/rHCL. Objective response (OR) is defined in OM#25 (Substudy B), 28 (Substudy C), and 29 (Substudy D).
    measure
    All Substudies (Substudies A, B, C and D): Time to First Objective Response
    time Frame
    Up to 2 years
  7. description
    Time to best objective response was defined as time from the date of brexucabtagene autoleucel infusion to the date of best response per the Sixth International Workshop in WM for r/rWM, per the Lugano Classification for r/rRT and r/r BL, and per Grever and colleagues for r/rHCL. Objective response (OR) is defined in OM#25 (Substudy B), 28 (Substudy C), and 29 (Substudy D).
    measure
    All Substudies (Substudies A, B, C and D): Time to Best Objective Response
    time Frame
    Up to 2 years
  8. description
    TEAE was defined as any adverse event with onset on or after the brexucabtagene autoleucel infusion.
    measure
    All Substudies (Substudies A, B, C and D): Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
    time Frame
    First infusion date of brexucabtagene autoleucel up to 2 years
  9. description
    Laboratory results were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE grading is a standardized system from the NCI that classifies the severity of side effects (adverse events) from cancer treatments, using a 1-5 scale: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), and Grade 5 (Death) The incidence of post-infusion worst-grade lab toxicities for all analytes were summarized.
    measure
    All Substudies (Substudies A, B, C and D): Number of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
    time Frame
    First infusion date of brexucabtagene autoleucel up to 2 years
  10. description
    Laboratory results were graded according to NCI CTCAE version 5.0. The incidence of post-infusion worst-grade lab toxicities for all analytes were summarized.
    measure
    All Substudies (Substudies A, B, C and D): Number of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher
    time Frame
    First dose date up to 2 years
  11. description
    Dose-limiting toxicity is defined as protocol-defined brexucabtagene autoleucel-related events with onset within the first 28 days following brexucabtagene autoleucel infusion.
    measure
    All Substudies (Substudies A, B, C and D): Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs)
    time Frame
    First infusion date of brexucabtagene autoleucel up to 28 days
  12. measure
    All Substudies (Substudies A, B, C and D): Number of Participants With Positive Anti-brexucabtagene Autoleucel Antibodies
    time Frame
    Up to 2 years
Full study description
brief Summary
Master protocol: The goal of this master clinical study is to test how well the study drug, brexucabtagene autoleucel, works in participants with rare B-cell malignancies: relapsed/refractory Waldenstrom macroglobulinemia (r/r WM) (Substudy A), r/r Richter transformation (RT) (Substudy B), r/r Burkitt lymphoma (BL) (Substudy C) and r/r hairy cell leukemia (HCL) (Substudy D).
detailed Description
This study will use a basket study design with separate, indication-specific substudies, to investigate r/r RT and r/r BL. After completing the treatment period, all participants will be followed in the post-treatment follow-up period. Thereafter, participants will transition to a separate long-term follow-up study (KT-US-982-5968) to continue follow-up out to 15 years. All substudies have been early terminated by the sponsor. Below is summary of enrollment in each Substudy: * Substudy-A This substudy was withdrawn. Therefore no participants were enrolled. * Substudy-B enrollment closed, actual enrollment is 6. * Substudy-C enrollment closed, actual enrollment is 12. * Substudy-D enrollment closed, actual enrollment is 1.
Source references
see Also Links
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-088fb9a5f8600a13d086
      requested nct id
      NCT05537766
      primary nct id
      NCT05537766
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      8b9a346048372591e3ee0de631ceead25528dc1d384a69971d454af93b26921d
      payload sha256
      116eb3f0b7e13798fced5bd9ee0bf7fb1c26f11cf58edc44046eb9e98e56a1ff
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-088fb9a5f8600a13d086
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT05537766
      occurrences
      1. context exact
        NCT05537766
        end
        11
        exact text
        NCT05537766
        start
        0
      offset unit
      unicode_code_points
      query cond
      Hairy Cell Leukemia
      query disease state id
      ds-hairy-cell-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-hairy-cell-leukemia-000.json
      source file sha256
      8b9a346048372591e3ee0de631ceead25528dc1d384a69971d454af93b26921d
      source json pointer
      /studies/20/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      6a9b8d3e9e243c7148a430bbf14fcdb374529a612ea36ee8868962725d9e597a
    2. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-356d443473ab7d0dbf6c
      requested nct id
      NCT05537766
      primary nct id
      NCT05537766
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      4b9f98c35791bb124616d1e37ac9bbb52187d289e2c286b1332c0895cb4a42c1
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-356d443473ab7d0dbf6c
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT05537766
      occurrences
      1. context exact
        NCT05537766
        end
        11
        exact text
        NCT05537766
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/485/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      6a9b8d3e9e243c7148a430bbf14fcdb374529a612ea36ee8868962725d9e597a

    Preserved source evidence · Not medical advice